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rt elements dose review brain metastases adaptive hybrid surgery analysis
Brainlab Ag
Summary: The rt elements dose review brain metastases by Brainlab Ag is a device for adaptive hybrid surgery analysis in brain metastases. It is FDA 510k cleared, with evidence supporting its use in improving local control of brain tumors.
FDA Clearance Information
Pathway
510K
Number
K142108 ↗
Decision Date
December 16, 2014
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on December 16, 2014. It is manufactured by Brainlab Ag and is classified as a Class 2 medical device.
What It Is
The rt elements dose review brain metastases is a clinician-facing device designed for adaptive hybrid surgery analysis in patients with brain metastases. It assists in precise radiation dose delivery and surgical planning.
Clinical Applications
This device is commonly used in the treatment of brain metastases, where precise radiation therapy is crucial. It aids in planning and executing adaptive hybrid surgeries to optimize patient outcomes.
Evidence Summary
The available literature includes 13 studies, comprising various study types such as RCTs and retrospective analyses, with publication years ranging from 2023 to 2024.
Reported Outcomes
Published studies report that the use of this device in brain metastases treatment has shown positive oncologic outcomes, including improved local control and preservation of cognitive function. The device's role in preoperative stereotactic radiosurgery has been highlighted as beneficial in managing intracranial neoplasms.
Safety Profile
Reported complications include potential radiotoxicity in the central nervous system, although proton therapy has been suggested to mitigate such risks. The safety profile is generally favorable, with limited adverse events reported.
Evidence Limitations
Current evidence is limited by the small number of clinical trials specifically evaluating this device. Further research is needed to fully understand its long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for rt elements dose review brain metastases?
The device is indicated for use in adaptive hybrid surgery analysis for patients with brain metastases, aiding in precise radiation therapy planning.
What outcomes have been reported in clinical studies?
Studies have reported improved local control of brain tumors and preservation of cognitive function when using this device.
What complications have been reported?
Reported complications include potential CNS radiotoxicity, though these are mitigated by advanced techniques like proton therapy.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.